Tokyo, June 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061770) titled 'Exploratory Study on the Dose-Dependent Efficacy and Functional Effects of Lactic Acid Bacteria Intake for Subjects Who Experience Temporary Discomfort Associated with the Menstrual Cycle' on June 3.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Miura Clinic, Medical Corporation Kanonkai

Condition: Condition - Healthy subjects Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy and functional effects of lactic acid bacteria intake in subjects who experience temporary discomfort associated with the menstrual cycle, and to determine the appropriate dose Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake test food 1 for 4 weeks Interventions/Control_2 - Intake test food 2 for 4 weeks

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - (1) Women aged 20 to 49 years. (2) Subjects who experience temporary discomfort associated with the menstrual cycle. (3) Subjects with a menstrual cycle of approximately 26 to 32 days, with a cycle variability within 6 days. (4) Subjects who received sufficient explanation about the purpose and procedures of the study, had the capacity to provide consent, voluntarily agreed to participate after fully understanding the study, and provided written informed consent. Key exclusion criteria - (1) Subjects with a history of diabetes, liver disease, renal disease, gastrointestinal disease, heart disease, respiratory disease, peripheral vascular disease, or other serious diseases. (2) Subjects who have undergone gastrointestinal surgery. (3) Subjects showing abnormal liver and kidney function test values. (4) Subjects with diseases currently being treated. (5) Subjects with food or drug allergies. (6) Subjects with symptoms of anemia. (7) Female subjects who wish to become pregnant during the study, or who are pregnant (including those who may be pregnant) or breastfeeding. (8) Subjects taking hormone medication. (9) Subjects who play intense sports or who are on a diet. (10) Subjects with extremely irregular eating habits. (11) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) or quasi-drugs during the study period. (12) Subjects who are continuously undergoing treatment with pharmaceuticals (including OTC and prescription medications). (13) Subjects who drink more than 40 g of pure alcohol per day on average. (14) Subjects who smoke an average of 21 or more cigarettes per day. (15) Subjects who are participating in or will participate in other clinical trials at the start of this study. (16) Subjects who are deemed inappropriate for the study by the principal investigator or subinvestigator. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 28 Day Date of IRB - 2026 Year 05 Month 28 Day Anticipated trial start date - 2026 Year 06 Month 04 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070648

Disclaimer: Curated by HT Syndication.